FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

FDA to Address ‘Narrow’ Labeling of In Vitro Companion Devices for Oncology Drugs

Dec. 12, 2018

The way in vitro companion diagnostics for cancer drugs are labeled sometimes presents a challenge for oncology care, FDA Commissioner Scott Gottlieb said last week in unveiling new guidance to tackle the problem.

Because in vitro diagnostic test approvals are frequently supported by studies of one specific drug, the labeling often reflects the diagnostic’s use with just that medicine. As a consequence, the drug’s labeling can also reflect its use with only that test.

Gottlieb noted an increase in new drugs targeting specific molecular markers that drive the growth and spread of cancer, sometimes with multiple drugs in a class of medicines targeting the same marker nearly the same way.

To address this issue, the agency is issuing new draft guidance that aims to make it easier to obtain class labeling on diagnostic tests for oncology treatments. The draft guidance recommends that the companion diagnostic’s intended use name the specific group or class of therapeutic products, if there is evidence to show the companion diagnostic is appropriate for use with that group or class.

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